NCT06093490

Detecting Absence Seizures Using Hyperventilation and Eye Movement Recordings

A Mobile Health Application to Detect Absence Seizures Using Hyperventilation and Eye-Movement Recordings

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 65 (actual)
• Sponsor: Eysz, Inc. · Industry
• Sex: All
• Age: 4 Years – 12 Years
• Healthy volunteers: —

Summary

This study is being done to find out if a smartphone app can identify absence seizures. Children who have a history of absence seizures, as well as children without any seizure history, will be testing out the app. If participating the child will be guided through hyperventilation, an activity that asks the child to take quick, deep breaths. The app will record video of the child's face and sounds they make during hyperventilation. Hyperventilation is a safe and established technique frequently used during EEG (electroencephalogram) to encourage seizure occurrence. The App will be used during a regularly scheduled EEG.

Detailed description

This observational study focuses on validating the use of the Eysz mHealth App - a smartphone-based tool for guided Hyperventilation (HV) and data collection - to aid clinicians in identifying absence seizures in people at risk for childhood absence epilepsy (CAE). The Eysz mHealth app will guide users through HV via interactive graphics while capturing audio and video data using smartphone sensors (e.g., camera, microphone) from which eye movements, facial biometrics/ expressions, number and length of exhales will be extracted. The goal of this observational study is to determine an epileptologist's performance in identifying HV-induced absence seizures using video data collected from a smartphone when compared to the gold standard interpretation of the EEG. The exploratory goal is to develop machine learning based algorithms to identify HV-induced seizures.

Conditions

• Absence Epilepsy, Childhood
• Absence Seizures
• Absence Epilepsy
• Epilepsy in Children
• Staring
• Seizures

Interventions

Type	Name	Description
DEVICE	Eysz Hyperventilation Recorder	App used to guide and record hyperventilation

Timeline

• Start date: 2023-12-01
• Primary completion: 2025-06-30
• Completion: 2025-07-30
• First posted: 2023-10-23
• Last updated: 2025-10-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study